This double-blind study required adult patients undergoing moderately to highly emetogenic chemotherapy regimes to establish the efficacy and safety of a single-dose, sustained release formulation of the test article for the prevention of acute- and delayed-onset chemotherapy-induced nausea and vomiting (CINV). This was one of the largest CINV trials to date. TFS was selected to provide full CRO services including site identification/initiation/training; patient enrollment; project management/monitoring; data management; biostatistics & programming; medical writing, and regulatory consulting.
Double-Blind Global Study (USA +/India/ Europe in Cancer patients)
